Fixed dimensional and bi-directional steerable catheter control handle

ABSTRACT

An apparatus for imparting a tensile force to deflect a distal portion of a catheter while maintaining its exterior dimensions may include a handle grip including a cross-section of generally predetermined exterior dimensions, and a longitudinal axis. A flexible elongate member may include proximal and distal end portions, with the proximal end portion being coupled to the handle grip. An adjustment knob may include a cross-section of generally predetermined exterior dimensions, and is rotatably coupled to the handle grip around the longitudinal axis. An elongate deflection member may be operably coupled to the adjustment knob and to the distal end portion of the elongate member. Rotation of the adjustment knob may impart a tensile force to the deflection member thereby causing the distal end portion of the elongate member to deflect from a prior configuration while maintaining the generally predetermined exterior dimensions of the handle grip and the adjustment knob.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. application Ser. No. 13/692,597filed 3 Dec. 2012, now allowed (the '597 application), which is acontinuation of U.S. application Ser. No. 12/346,653 filed 30 Dec. 2008,now U.S. Pat. No. 8,323,239 (the '653 application), which is acontinuation of U.S. application Ser. No. 11/023,667 filed 28 Dec. 2004,now U.S. Pat. No. 7,691,095 (the '667 application). The '597application, the '653 application, and the '667 application are herebyincorporated by reference as though fully set forth herein.

BACKGROUND OF THE INVENTION

a. Field of the Invention

The present invention relates to catheters and sheaths and methods ofusing catheters and sheaths. More particularly, the present inventionrelates to a fixed dimensional control handle for steerable cathetersand sheaths and methods of manufacturing and using such an handle, withthe control handle generally maintaining its exterior dimensions duringoperation thereof.

b. Background Art

Catheters (i.e., catheters or sheaths) that have flexible tubular bodieswith deflectable distal ends and control handles for controlling distalend deflection are used for many noninvasive medical procedures. Forexample, catheters having conductive electrodes along the distal ends oftheir bodies are commonly used for intra-cardiac electrophysiologystudies. The distal end of a catheter body is typically placed into apatient's heart to monitor and/or record the intra-cardiac electricalsignals during electrophysiology studies or during intra-cardiacmapping. The orientation or configuration of the distal end iscontrolled via an actuator located on the catheter's control handle,which remains outside the patient's body. The electrodes conduct cardiacelectrical signals to appropriate monitoring and recording devices thatare operatively connected at the control handle.

Typically, a catheter body is cylindrical and electricallynon-conductive. The catheter body includes a flexible tube constructedfrom polyurethane, nylon or other electrically non-conductive flexiblematerial. The catheter body further includes braided steel wires orother non-metallic fibers in its wall as reinforcing elements. Eachelectrode has a relatively fine electrically conductive wire attachedthereto and extending through the catheter body. The conductive wireextends from the distal end to a proximal end where electricalconnectors such as plugs or jacks are provided to be plugged into acorresponding socket provided in a recording or monitoring device.

The distal portion of the catheter body is selectively deformed into avariety of curved configurations using the actuator on the controlhandle. The actuator is commonly internally linked to the distal portionof the catheter body by at least one deflection wire. Some catheterbodies employ a single deflection wire, which is pulled (i.e., placed intension) by the actuator in order to cause the distal portion of thecatheter body to deform. Other catheter bodies have at least twodeflection wires, where the displacement of one wire (i.e., placing onewire in tension) results in the other wire going slack (i.e., the wiredoes not carry a compressive load). In such catheters, where thedeflection wires are not adapted to carry compressive loads (i.e., thedeflection wires are only meant to be placed in tension), the deflectionwires are commonly called pull or tension wires.

To deform the distal end of the catheter body into a variety ofconfigurations, a more recent catheter design employs a pair ofdeflection wires that are adapted such that one of the deflection wirescarries a compressive force when the other deflection wire carries atensile force. In such catheters, where the deflection wires are adaptedto carry both compressive and tension loads, the deflection wires arecommonly called push/pull or tension/compression wires and thecorresponding catheter actuators are called push-pull actuators. U.S.Pat. No. 5,861,024 to Rashidi, which issued Jan. 19, 1999, isrepresentative of a push-pull actuator of this type, and the detailsthereof are incorporated herein by reference.

Prior art control handles for controlling distal end deflection ofcatheter bodies have several drawbacks that adversely impact thehandles' ability to be operated precisely by a single hand. First, thecontrol handles are often excessively bulky. Second, the control handlesare often inadequate with respect to their ability to provide finelycontrolled deflection adjustment for the distal end of the catheterbody. Third, the control handles often provide inadequate deflectionwire travel for a desired medical procedure. Fourth, the control handlesoften have a mechanical advantage that is less than desirable and, as aresult, require significant effort to operate on the part of a user.Fifth, once a desired body distal end deflection has been reached, thecontrol handles typically require the physician to take a conscious stepto maintain the catheter at the desired deflection. Sixth, the wiredisplacement mechanisms within the control handles have a tendency topermanently deform the deflection wires. Seventh, the wire displacementmechanisms within the control handles typically make it difficult, ifnot impossible, to provide a lumen that runs uninterrupted from theproximal end of the control handle to the distal end of the catheterbody.

There is a need in the art for a catheter control handle that offersimproved single hand operation and deflection adjustment of the distalend of the catheter body. There is also a need in the art for such ahandle with a lumen there through. There is also a need in the art for amethod of manufacturing and using such a control handle.

BRIEF SUMMARY OF INVENTION

A fixed dimensional and bi-directional steerable catheter control handlemay include an apparatus for imparting a tensile force to deflect adistal portion of a catheter while maintaining its exterior dimensions.The apparatus may include a handle grip including generally oval orcircular cross-sections of generally predetermined exterior dimensions,and a longitudinal axis. A flexible elongate member may include proximaland distal end portions, with the proximal end portion being coupled tothe handle grip. An adjustment knob may include a generally circularcross-section of generally predetermined exterior dimensions, and may berotatably coupled to the handle grip around the longitudinal axis of thehandle grip. One or more elongate deflection members may be operablycoupled to the adjustment knob and to the distal end portion of theelongate member. Rotation of the adjustment knob may impart a tensileforce to the elongate deflection member thereby causing the distal endportion of the elongate member to deflect from a prior configurationwhile maintaining the generally predetermined exterior dimensions of thehandle grip and the adjustment knob.

For the apparatus described above, in an embodiment, the elongatedeflection member may include a filament, a braided cord, or aresin-based member. In an embodiment, the adjustment knob may beoperably coupled to an intermediate body portion or a distal portion ofthe handle grip. In an embodiment, the elongate deflection member mayinclude a first pull wire. The apparatus, in an embodiment, may includeone or more additional pull wires operably coupled to the adjustmentknob.

For the apparatus described above, in an embodiment, the apparatus mayinclude means for simultaneously imparting a tensile force to the firstpull wire and releasing a tensile force on the additional pull wire. Theadjustment knob may include an interior surface forming an aperturegenerally orthogonally oriented with respect to the longitudinal axis ofthe handle grip, with the interior surface including one or more sets ofthreaded grooves which cooperate with the means. The means forsimultaneously imparting may include a pair of generally axiallydisplaceable members disposed within the handle grip, and rotation ofthe adjustment knob may impart opposing forces to the axiallydisplaceable members.

For the apparatus described above, in an embodiment, the elongate membermay include one or more longitudinal lumens. In an embodiment, theapparatus may include one or more electrodes coupled to the elongatemember. The elongate member, in an embodiment, may include abiocompatible electrically insulative material. The electricallyinsulative material may be a flexible material. Alternatively, theelectrically insulative material may include a polyurethane material ora nylon material. The apparatus, in an embodiment, may include one ormore reinforcing elements disposed within a portion of the elongatemember. The reinforcing element may include braided members, which mayinclude a conductive material.

For the apparatus described above, in an embodiment, the elongate membermay include a segment of a braided metallic wire and/or a non-metallicfiber. The apparatus, in an embodiment, may include a hemostasis valvecoupled to the handle grip. In an embodiment, an exterior surface of theadjustment knob may includes a generally longitudinal groove and/or agenerally longitudinal protuberance.

For the apparatus described above, in an embodiment, the priorconfiguration may include a substantially straight configuration. In anembodiment, the elongate deflection member may include an elongate wire.In an embodiment, the apparatus may include an anchor ring coupled tothe distal portion of the elongate member, and the elongate deflectionmember may include one or more elongate pull wires coupled to the anchorring.

In an embodiment, an apparatus for imparting a tensile force to deflecta distal portion of a catheter while maintaining its exterior dimensionsmay include a handle grip including a cross-section of generallypredetermined exterior dimensions, and a longitudinal axis. A flexibleelongate member may include proximal and distal end portions, with theproximal end portion being coupled to the handle grip. An adjustmentknob may include a cross-section of generally predetermined exteriordimensions, and be rotatably coupled to the handle grip around thelongitudinal axis of the handle grip. One or more elongate deflectionmembers may be operably coupled to the adjustment knob and to the distalend portion of the elongate member. Rotation of the adjustment knob mayimpart a tensile force to the elongate deflection member thereby causingthe distal end portion of the elongate member to deflect from a priorconfiguration while maintaining the generally predetermined exteriordimensions of the handle grip and the adjustment knob.

For the apparatus described above, the handle grip may include agenerally oval or circular cross-section, and in an embodiment, theadjustment knob may include a generally circular cross-section.

In an embodiment, an apparatus for imparting a tensile force to deflecta distal portion of a catheter while maintaining its exterior dimensionsmay include a substantially hollow handle grip having a tactile outersurface having a longitudinal axis. An adjustment knob having a tactileouter surface may be coupled to the handle grip approximatelyequidistant from the longitudinal axis. A relatively thin elongatedflexible body may have a distal end portion and a proximal portion, withthe proximal portion coupled to the handle grip. One or more elongatedmembers may be operatively coupled to the adjustment knob and to thedistal end portion. Means may be disposed within the handle grip andoperatively coupled to the adjustment knob for imparting a tensile forceto the elongated member when the adjustment knob is rotated about thelongitudinal axis so that the distal end portion of the flexible bodydeflects from a first configuration to a second configuration. Thetactile outer surfaces of the handle grip and the adjustment knob may besubstantially unchanged when the flexible body is disposed in the firstand second configurations.

For the apparatus described above, the handle grip may include agenerally oval or circular cross-section, and in an embodiment, theadjustment knob may include a generally circular cross-section.

The foregoing and other aspects, features, details, utilities, andadvantages of the invention will be apparent from reading the followingdescription and claims, and from reviewing the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an isometric view of one embodiment of the present invention,which is a control handle for a catheter or sheath.

FIG. 2 is an isometric view of the handle exploded to show its variouscomponents.

FIG. 3 is a longitudinal sectional elevation of the handle taken alongsection line AA of FIG. 1.

FIG. 4 is an isometric view of the right and left slides with theirrespective deflection wires attached.

FIG. 5 is a side elevation of an exemplary slide illustrating a means ofsecuring a deflection wire to the proximal end of the slide.

FIG. 6 is a longitudinal sectional elevation of the adjusting knob takenalong section line AA of FIG. 1.

FIG. 7 is a plan view of another embodiment of the handle.

FIG. 8 is a side elevation of the handle depicted in FIG. 7.

FIG. 9 is an isometric view of the distal end of the handle depicted inFIG. 7.

FIG. 10 is a longitudinal sectional plan view of the handle taken alongsection line BB of FIG. 9.

FIG. 11 is a longitudinal sectional plan view of the knob taken alongsection line BB in FIG. 9.

FIG. 12 is a right side isometric view of the slides displaced about thewire guide.

FIG. 13 is a left side isometric view of the slides displaced about thewire guide.

FIG. 14 is a longitudinal sectional elevation of the handle grip takenalong section line CC in FIG. 7.

FIG. 15 is a latitudinal sectional elevation of the handle grip takenalong section line DD in FIG. 8.

FIG. 16 is an isometric view of the distal end of a control handle for acatheter wherein the handle has a through lumen.

FIG. 17 is an isometric view of the slides, the wire guide, the wiretubing, and the lumen illustrating the path the lumen takes through thehandle.

FIG. 18 is an elevation view of the extreme proximal end surfaces of theslides as viewed from arrow A in FIG. 17 and illustrating the path thelumen and wire tubing take into the passage formed by the channels ofthe slides.

FIG. 19 is an isometric view of the lumen, deflection wires, andelectrical wires of the tube exiting the catheter body-retaining nut onthe distal end of the handle.

FIG. 20 is an isometric view of another embodiment of the handleexploded to show its various components.

FIG. 21 is a longitudinal sectional elevation taken along section lineZZ in FIG. 20.

FIG. 22 is isometric views of the slides oriented to show theirrespective portions of the passage and their planar slide faces.

FIG. 23 is an isometric view of another embodiment of the handleexploded to show its various components.

FIG. 24 is a longitudinal sectional elevation of the handle taken alongsection line YY of FIG. 23.

FIG. 25 is the same longitudinal sectional elevation of the adjustingknob as depicted in FIG. 24, except the adjusting knob is shown byitself.

FIG. 26 is a side elevation of the slides.

FIG. 27A is a latitudinal sectional elevation of the handle, as takenalong section line XX in FIG. 24, wherein the wire guide has a squarecross section.

FIG. 27B is the same latitudinal sectional elevation depicted in FIG.27A, except the wire guide has a circular cross section and a key/groovearrangement.

FIG. 28 is a side elevation of one embodiment of the wire guide equippedwith a groove.

FIG. 29 is a longitudinal sectional elevation of another embodiment ofthe handle taken along section line YY of FIG. 23.

FIG. 30 is a longitudinal sectional plan view of the handle depicted inFIG. 29 taken along section line VV in FIG. 23 and wherein section lineVV forms a plane that is perpendicular to the plane formed by sectionline YY in FIG. 23.

FIG. 31 is an isometric view of one embodiment of the wire guide.

FIG. 32 is a latitudinal sectional elevation of the handle as takenalong section line WW in FIG. 29.

FIG. 33 is a longitudinal sectional elevation of the handle taken alongsection line AA of FIG. 1.

FIG. 34 is a side elevation of an exemplary slide employed in theembodiment depicted in FIG. 33.

FIG. 35 is a longitudinal sectional elevation of the adjusting knobtaken along section line AA of FIG. 1.

FIG. 36 is a diagrammatic illustration of the control handle of thesubject invention being employed in a surgical procedure on a patient.

DETAILED DESCRIPTION OF THE INVENTION

Referring FIG. 1 is an isometric view of one embodiment of the presentinvention, which is a control handle 2 for a flexible tubular body 4 ofa catheter 5. Throughout this specification, the term catheter is meantto include, without limitation, catheters, sheaths and similar medicaldevices. As shown in FIG. 1, in one embodiment, the distal end of thehandle 2 is connected to the catheter body 4 and the proximal end of thehandle 2 is connected to tubing 6 that contains electrical wire andextends to an electrical connector 8. The handle 2 includes an adjustingknob 10 and a handle grip 12. As will become clear from thisspecification, the handle 2 of the present invention is advantageous inthat it is compact and allows a user to manipulate the catheter body'sextreme distal end 14 in a bi-directional manner by pivoting theadjusting knob 10 relative to the handle grip 12 in one direction or theother about the longitudinal axis of the handle 2. Furthermore, in oneembodiment, the handle 2 has a lumen that runs uninterrupted from theproximal end of the handle 2 to the extreme distal end 14 of thecatheter body 4. This lumen can be used to provide contrast injectionfor guide wire insertion.

For a more detailed discussion of the handle 2, reference is now made toFIGS. 2 and 3. FIG. 2 is an isometric view of the handle 2 exploded toshow its various components. FIG. 3 is a longitudinal sectionalelevation of the handle 2 taken along section line AA of FIG. 1.

As shown in FIGS. 2 and 3, the adjusting knob 10 is pivotally attachedto a mounting shaft (i.e., a slide base or base portion) 16 containedwithin the handle grip 12. To pivotally attach the knob 10 to themounting shaft 16, a dowel pin 18 is inserted into a pinhole 20 in thedistal end of the shaft 16 and mates with a groove 22 in a hub portion23 of the knob 10. A silicone o-ring 24 exists between the hub portion23 of the knob 10 and the distal end of the shaft 16.

As indicated in FIGS. 2 and 3, a wire guide 26 is positioned within theadjusting knob 10 and is held in place by a retaining ring 28. A rightslide or member 30 and a left slide or member 32 are slideablypositioned within a slot (i.e., a slide compartment) 34 in the mountingshaft 16. A catheter body-retaining nut 36 is used to secure thecatheter body 4 to the distal end of the wire guide 26.

As illustrated in FIG. 3, a pair of deflection wires 38 extend from theextreme distal end 14 of the body 4, through the body 4, the wire guide26 and a passage 40 formed between the two slides 30, 32, to a pointnear a proximal portion of the slides 30, 32. Each wire 38 then affixesto an individual slide 30, 32 via a retention screw 42.

For a more detailed discussion of the slides 30, 32 and theirrelationship to the deflection wires 38, reference is now made to FIG.4, which is an isometric view of the deflection wires 38 a, 38 battached to the right and left slides 30, 32. As shown in FIG. 4, theslides 30, 32, which are mirror images of each other, each have arectangular box-like proximal portion 44 and a half-cylinder distalportion 46. Each proximal portion 44 has a generally planar outersidewall and bottom wall. These planar surfaces slideably displaceagainst the generally planar sides and bottom of the slot 34, which actas thrust surfaces for the slides 30, 32.

Each half-cylinder distal portion 46 is hollowed out along itslongitudinal axis to form the passage 40 through which the deflectionwires 38 a, 38 b and, as indicated in FIG. 3, the narrow proximalportion of the wire guide 26 extend when the slides 30, 32 are in theassembled handle 2. Each slide 30, 32 has a planar slide face 48 that ismeant to slideably abut against the planar slide face 48 of the opposingslide 30, 32. Thus, as illustrated in FIG. 2, when the planar slidefaces 48 of the slides 30, 32 abut against each other and the extremeproximal ends of each slide 30, 32 are flush with each other, thehalf-cylinder distal portions 46 of each slide 30, 32 combine to form acomplete cylinder with a channel or passage 40 there through.

As shown in FIG. 4, in one embodiment, the proximal end of eachdeflection wire 38 a, 38 b forms a loop 50 through which a retentionscrew 42 passes to secure the wire 38 a, 38 b to the proximal portion ofthe respective slide 30, 32. As indicated in FIG. 5, which is a sideelevation of an exemplary slide 30, in one embodiment, the proximal endof each deflection wire 38 forms a knot 52. The wire 38 passes through ahollow tension adjustment screw 54 and the knot 52 abuts against thehead 55 of the screw 54, thereby preventing the wire 38 from beingpulled back through the screw 54. In one embodiment, the screw'slongitudinal axis and the longitudinal axis of the slide 30, 32 aregenerally parallel. Each tension adjustment screw 54 is threadablyreceived in the proximal end of its respective slide 30, 32. Tension ina wire 38 may be increased by outwardly threading the wire's tensionadjustment screw 54. Conversely, tension in a wire 38 may be decreasedby inwardly threading the wire's tension adjustment screw 54.

As can be understood from FIG. 4, in one embodiment where the wires 38a, 38 b are intended to only transmit tension forces, the wires 38 a, 38b may deflect or flex within an open area 45 defined in the proximalportion 44 of each slide 30, 32 when the slides 30, 32 displacedistally. Similarly, as can be understood from FIG. 5, in anotherembodiment where the wires 38 are intended to only transmit tensionforces, the wires 38 may slide proximally relative to the screw 54 whenthe slides 30, 32 displace distally.

As shown in FIG. 4, in one embodiment, the outer circumference of thehalf-cylinder distal portion 46 of the right slide 30 is threaded with aright-hand thread 56, and the outer circumference of the half-cylinderdistal portion 46 of the left slide 32 is threaded with a left-handthread 58. In one embodiment, the outer circumference of thehalf-cylinder distal portion 46 of the right slide 30 is threaded with aleft-hand thread, and the outer circumference of the half-cylinderdistal portion 46 of the left slide 32 is threaded with a right-handthread.

For a better understanding of the relationship of the slide threads 56,58 to the rest of the handle 2, reference is now made to FIG. 6, whichis a longitudinal sectional elevation of the adjusting knob 10 takenalong section line AA of FIG. 1. As indicated in FIG. 6, a cylindricalhole or shaft 60 passes through the knob 10 along the knob'slongitudinal axis. In the hub portion 23 of the knob 10, the innercircumferential surface of the shaft 60 has both right hand threads 62and left hand threads 64. These internal threads 62, 64 of the knob 10mate with the corresponding external threads 56, 58 of the slides 30,32. More specifically, the right internal threads 62 of the knob 10 matewith the right external threads 56 of the right slide 30, and the leftinternal threads 64 of the knob 10 mate with the left external threads58 of the left slide 32.

Thus, as can be understood from FIGS. 2, 3, 4 and 6, in one embodiment,as the knob 10 is rotated clockwise relative to the longitudinal axis ofthe handle 2, the internal and external right threads 62, 56 engage andthe internal and external left threads 64, 58 engage, thereby causingsimultaneous opposed displacement of the right and left slides 30, 32longitudinally within the slot 34 in the handle 10. Specifically,because of the threading arrangement of the knob 10 and the slides, 30,32, the right slide 30 moves distally within the slot 34 and the leftslide 32 moves proximally within the slot 34 when the knob 10 is rotatedclockwise relative to the handle grip 12 of the handle 2. Conversely,when the knob 10 is rotated in a counterclockwise manner relative to thehandle grip 12 of the handle 2, the right slide 30 moves proximallywithin the slot 34 and the left slide 32 moves distally within the slot34.

As can be understood from FIGS. 4 and 6, when the knob 10 is rotatedsuch that the right slide 30 is urged distally and the left slide 32 isurged proximally, the deflection wire 38 a connected to the right slide30 is placed into compression and the deflection wire 38 b connected tothe left slide 32 is placed into tension. This causes the extreme distalend 14 of the catheter body 4 to deflect in a first direction.Conversely, when the knob 10 is rotated such that the right slide 30 isurged proximally and the left slide 32 is urged distally, the deflectionwire 38 a connected to the right slide 30 is placed into tension and thedeflection wire 38 b connected to the left slide 32 is placed intocompression. This causes the extreme distal end 14 of the catheter body4 to deflect in a second direction that is opposite the first direction.

The control handle 2 of the present invention as described has severaladvantages. First, the handle 2 is compact and may be operated with asingle hand. Second, the threaded slides 30, 32 and knob 10 allow aphysician to make fine, controlled adjustments to the bend in the distalend 14 of the catheter body 4. Third, once the knob 10 is rotated so asto cause a bend in the distal end 14 of the catheter body 4, the threads56, 58, 62, 64 interact to maintain the bend without requiring anyaction on the physician's part. Fourth, because the slides 30, 32 simplydisplace distally and proximally along the longitudinal axis of thehandle 2, they are less likely to permanently deform the wires 38 ascompared to the wire displacement mechanisms in some prior art handles.Fifth, the threads 56, 58, 62, 64 are mechanically advantageous in thatthey provide increased deflection wire travel and reduced actuationeffort for the physician, as compared to some prior art handles.

While FIGS. 2-6 depict an embodiment where the slides 30, 32 haveexternal threads 56, 58 and the knob 10 has internal threads 62, 64, inother embodiments the threading arrangement is reversed. For adiscussion of one such embodiment, reference is made to FIGS. 33-35.FIG. 33 is a longitudinal sectional elevation of the handle 2 takenalong section line AA of FIG. 1. FIG. 34 is a side elevation of anexemplary slide employed in the embodiment depicted in FIG. 33. FIG. 35is a longitudinal sectional elevation of the adjusting knob taken alongsection line AA of FIG. 1.

A comparison of the embodiment depicted in FIGS. 33-35 to the embodimentdepicted in FIGS. 3, 5 and 6 reveals that the two embodiments aregenerally the same, except as will be described in the followingdiscussion of FIGS. 33-35. Reference numbers utilized in FIGS. 33-35pertain to the same or similar features identified by the same referencenumbers in FIGS. 3, 5 and 6.

As shown in FIG. 33, the adjusting knob 10 is pivotally attached to amounting shaft (i.e., a slide base or base portion) 16 contained withinthe handle grip 12. A wire guide 26 is positioned within the adjustingknob 10. Like the embodiment depicted in FIG. 2, the embodimentillustrated in FIG. 33 includes a right slide or member 30 and a leftslide or member 32 that are slideably positioned within a slot (i.e., aslide compartment) 34 in the mounting shaft 16.

As can be understood from FIG. 34, the slides 30, 32, which are mirrorimages of each other, each have a rectangular box-like proximal portion44 and a distal portion 46 that may be rectangular or half-cylindrical.Each proximal portion 44 has a generally planar outer sidewall andbottom wall. These planar surfaces slideably displace against thegenerally planar sides and bottom of the slot 34, which act as thrustsurfaces for the slides 30, 32.

Each distal portion 46 is hollowed out to form half of a cylindricalpassage 40 that is created when the slides 30, 32 are abutted againsteach other in a side-by-side relationship. Thus, each distal portion 46of each slide 30, 32 includes an inner circumferential surface, whichwhen combined with the inner circumferential surface of the other slide30, 32, defines the cylindrical passage 40.

As indicated in FIG. 34, in one embodiment, the inner circumferentialsurface of the right slide 30 is threaded with a right-hand thread 56.Similarly, as can be understood from FIG. 34, the inner circumferentialsurface of the left slide 32 is threaded with a left-hand thread 58.Thus, the distal portion 46 of each slide 30, 32 is equipped withinternal threads. In another embodiment, the inner circumferentialsurface of the right slide 30 is threaded with a left-hand thread 58.Similarly, the inner circumferential surface of the left slide 32 isthreaded with a right-hand thread 56.

As indicated in FIG. 35, the knob 10 includes an outer hub 23 asurrounding an inner hub 23 b. A space 65 exists between, and is definedby, the inner and outer hubs 23 a, 23 b. The space 65 is adapted toreceive the distal ends 46 of each slide 30, 32. The outercircumferential surface of the inner hub 23 b has both right handthreads 62 and left hand threads 64. These external threads 62, 64 ofthe knob 10 mate with the corresponding internal threads 56, 58 of theslides 30, 32. More specifically, the right external threads 62 of theknob 10 mate with the right internal threads 56 of the right slide 30,and the left external threads 64 of the knob 10 mate with the leftinternal threads 58 of the left slide 32.

As can be understood from FIG. 33, in one embodiment, as the knob 10 isrotated clockwise relative to the longitudinal axis of the handle 2, theinternal and external right threads 56, 62 engage and the internal andexternal left threads 58, 64 engage, thereby causing simultaneousopposed displacement of the right and left slides 30, 32 longitudinallywithin the slot 34 in the handle 10. Specifically, because of thethreading arrangement of the knob 10 and the slides, 30, 32, the rightslide 30 moves distally within the slot 34 and the left slide 32 movesproximally within the slot 34 when the knob 10 is rotated clockwiserelative to the handle grip 12 of the handle 2. Conversely, when theknob 10 is rotated in a counterclockwise manner relative to the handlegrip 12 of the handle 2, the right slide 30 moves proximally within theslot 34 and the left slide 32 moves distally within the slot 34.

As can be understood from FIG. 33, when the knob 10 is rotated such thatthe right slide 30 is urged distally and the left slide 32 is urgedproximally, the deflection wire 38 connected to the right slide 30 isplaced into compression and the deflection wire 38 connected to the leftslide 32 is placed into tension. This causes the extreme distal end 14of the catheter body 4 to deflect in a first direction. Conversely, whenthe knob 10 is rotated such that the right slide 30 is urged proximallyand the left slide 32 is urged distally, the deflection wire 38connected to the right slide 30 is placed into tension and thedeflection wire 38 connected to the left slide 32 is placed intocompression. This causes the extreme distal end 14 of the catheter body4 to deflect in a second direction that is opposite the first direction.

For a detailed discussion of another embodiment of the handle 2 of thepresent invention, reference is now made to FIGS. 7, 8 and 9. FIG. 7 isa plan view of the handle 2. FIG. 8 is a side elevation of the handle 2.FIG. 9 is an isometric view of the distal end of the handle 2.

As shown in FIGS. 7-9, the handle 2 includes an adjusting knob 10 on itsdistal end and a handle grip 12 on its proximal end. As can beunderstood from FIGS. 7-9, in one embodiment, the knob 10 has agenerally circular cross-section and the handle grip 12 has a generallyoval cross-section. In one embodiment, both the knob 10 and the handlegrip 12 have generally circular cross-sections. The oval cross-sectionof the handle grip 12 is advantageous because it provides the physicianwith a tactile indication of the catheter's rotational position.

For a more detailed discussion of the components of the handle 2,reference is now made to FIG. 10, which is a longitudinal sectional planview of the handle 2 taken along section line BB of FIG. 9. As shown inFIG. 10, an o-ring 24 is located between the handle grip 12 and a groovein the knob 10. The knob 10 is pivotally affixed to the handle grip 12via a rotating retaining-ring 60 that resides within grooves in both theknob and the handle grip 12.

As illustrated in FIG. 10, a catheter body-retaining nut 36 isthreadably affixed to the distal end of a wire guide 26 that extendsalong the axial center of the knob 10. As indicated in FIG. 10 and moreclearly shown in FIG. 11, which is a longitudinal sectional plan view ofthe knob 10 taken along section line BB in FIG. 9, a cylindrical hole orshaft 60 passes through the knob 10 along the knob's longitudinal axis.The inner circumferential surface of the shaft 60 has both right handthreads 62 and left hand threads 64 that extend towards the distal endof the knob 10 from a hub portion 23 of the knob 10. As shown in FIG.11, in one embodiment, the knob 10 is a singular integral piece.

As indicated in FIG. 10, a right slide 30 and a left slide 32 arelongitudinally displaceable within the handle 2 and about the proximalend of the wire guide 26. As shown in FIGS. 12 and 13, which are,respectively, a right side isometric view of the slides 30, 32 displacedabout the wire guide 26 and a left side isometric view of the slides 30,32 displaced about the wire guide 26, each slide 30, 32 has a planarslide face 48 that abuts and slideably displaces against the slide face48 of the opposed slide 30, 32. Also, each slide 30, 32 has a channel 40that combines with the channel 40 of the opposed slide 30, 32 to form apassage 40 through which the proximal end of the wire guide 26 passes asthe slides 30, 32 displace about the wire guide 26. As shown in FIG. 10,the passage 40 formed by the channels 40 also provides a pathway alongwhich the deflection wires 38 a, 38 b (represented by dashed lines inFIG. 10) travel from a proximal portion of the slides 30, 32, throughthe wire guide 26, and onward to the extreme distal end 14 of thecatheter body 4.

As indicated in FIGS. 12 and 13, each slide 30, 32 has a half-cylinderdistal portion 46 and a shorter and wider half-cylinder proximal portion47. The right slide 30 has a right-handed thread 56 on its distalportion 46. Similarly, the left slide 32 has a left-handed thread 58 onits distal portion 46. Thus, as can be understood from FIG. 10, when theknob 10 is rotated in a clockwise direction relative to the handle grip12, the right handed threads 62 within the knob 10 engage the righthanded threads 56 of the right slide 30, and the left handed threads 64within the knob 10 engage the left handed threads 58 of the left slide32. As a result, the right slide 30 is distally displaced within thehandle 2 and the left slide 32 is proximally displaced within the handle2. Accordingly, the deflection wire 38 a attached to the right slide 30is pushed (i.e., subjected to a compressive force) and the deflectionwire 38 b attached to the left slide 32 is pulled (i.e., subjected to atension force). Conversely, if the knob is rotated counterclockwise, theopposite displacement of the slides 30, 32 and deflection wires 38 a, 38b will occur.

As indicated in FIG. 10, each deflection wire 38 a, 38 b is attached tothe proximal portion 47 of its respective slide 30, 32 via retentionscrews 42. The retention screws, which are more clearly illustrated inFIGS. 12 and 13, are threadably mounted in the proximal portions 47.

As shown in FIGS. 12 and 13, each half-cylindrical proximal portion 47of a slide 30, 32 has an upper and lower planar notch 64 adjacent theirrespective planar slide faces 47. The function of these notches 64 maybe understood by referring to FIGS. 14 and 15.

FIG. 14 is a longitudinal section elevation of the handle grip 12 takenalong section line CC in FIG. 7. FIG. 15 is a latitudinal sectionelevation of the handle grip 12 taken along section line DD in FIG. 8.As shown in FIGS. 14 and 15, the handle grip 12 is one integral piecehaving an interior cylindrical void 66 in which the proximal portions 47of the slides 30, 32 may displace as indicated in FIG. 10.

As shown in FIGS. 14 and 15, upper and lower ribs 68 extend from thewalls that form the interior cylindrical void 66. The ribs 68 runlongitudinally along a substantial portion of the cylindrical void'slength. As can be understood from FIGS. 12-15, the upper planar notches64 on the proximal portions 47 of the slides 30, 32 interface with, anddisplace along, the upper rib 68 as the slides 30, 32 displace withinthe cylindrical void 66. Similarly, the lower planar notches 64 on theproximal portions 47 of the slides 30, 32 interface with, and displacealong, the lower rib 68 as the slides 30, 32 displace within thecylindrical void 66. Thus, the ribs 68 act as thrust surfaces for theslides 30, 32.

For a detailed discussion of another embodiment of the handle 2 depictedin FIGS. 7-15, reference is now made to FIG. 16. FIG. 16 is an isometricview of the distal end of a control handle 2 for a catheter 5 whereinthe handle 2 and catheter body 4 have a through lumen 70. As shown inFIG. 16, in one embodiment, the lumen 70 and the electrical wire tube 6,which extends to the electrical connector 8, pass through strain reliefs71 and into the proximal end of the handle grip 12. In one embodiment,the lumen 70 terminates at its proximal end with a stopcock 72. In oneembodiment, the stopcock 72 has a hemostasis seal 74 that can beutilized for guide wire insertion. While a long flexible length of lumen70, as depicted in FIG. 16, provides motion isolation while insertingcontrast from a syringe, in one embodiment, the lumen 70 does not extendfrom the handle grip 12. Instead, the stopcock 72 or luer fitting issimply attached to the lumen 70 where it exits the proximal end of thehandle grip 12.

For a better understanding of the path of the lumen 70, reference is nowmade to FIGS. 17, 18 and 19. FIG. 17 is an isometric view of the slides30, 32, the wire guide 26, the wire tubing 6, and the lumen 70illustrating the path the lumen 70 takes through the handle 2. FIG. 18is an elevation view of the extreme proximal end surfaces of the slides30, 32 as viewed from arrow A in FIG. 17 and illustrating the path thelumen 70 and wire tubing 6 take into the passage 40 formed by thechannels 40 of the slides 30, 32. FIG. 19 is an isometric view of thelumen 70, deflection wires 38 a, 38 b, and electrical wires 76 of thewire tube 6 exiting the catheter body-retaining nut 36 on the distal endof the handle 2.

As shown in FIGS. 17 and 18, the lumen 70 and the wire tubing 6 passthrough their respective reliefs 71 and into the passage 40 formed bythe channels 40 in each slide 30, 32. In one embodiment, soon after thewire tubing 6 and the lumen 70 enter the passage 40, the wires 76 of thewile tubing 6 exit the wire tubing 6 and are dispersed about the outercircumference of the lumen 70 as depicted in FIG. 19.

As illustrated in FIG. 17, in another embodiment, after the wire tube 6and lumen 70 enter the passage 40, the wire tube 6 and the lumen 70continue on their pathway to the distal end 14 of the catheter body 4 bypassing, in a side-by-side arrangement, through the remainder of thepassage 40 formed into the slides 30, 32 and into an internal passagethat extends along the longitudinal axis of the wire guide 26. Near theend of the wire guide 26, the wire 76 exists the wire tube 6. The wire76, lumen 70 and deflection wires 38 a, 38 b then pass into the catheterby exiting the catheter body-retaining nut 36 of the handle as indicatedin FIG. 19.

For a detailed discussion of another embodiment of the handle 2,reference is now made to FIG. 20, which is an isometric view of thehandle 2 exploded to show its various components. As can be understoodfrom FIG. 20, the features of the handle 2 depicted in FIG. 20 aresimilar to the features of the handle depicted in FIG. 2, except thehandle 2 depicted in FIG. 20 is configured to have a relatively large,generally uniform in diameter, pathway extend the full length of thehandle 2 (i.e., from the distal opening 102 in the wire guide 26,through the passage 40 defined in the slides 30, 32 and through an exithole 104 in the proximal end of the shaft 16).

The configuration of the handle 2 that allows a relatively largegenerally uniform in diameter pathway to pass through the length of thehandle 2, as depicted in FIG. 20, is more clearly shown in FIG. 21,which is a longitudinal sectional elevation taken along section line ZZin FIG. 20. As illustrated in FIG. 21, in one embodiment, the pathway100, which includes the passage through the wire guide 26 and thepassage 40 through the slides 30, 32, is large enough that the catheterbody 4 itself may pass through the pathway 100 and be connected to theproximal end of the shaft 16 at the exit hole 104. Thus, in oneembodiment, to prevent the catheter body 4 from rotating with theadjusting knob 10, the catheter body 4 is affixed to the shaft 16 at theexit hole 104. In one embodiment, the catheter body 4 runs the fulllength of the handle 4 as depicted in FIG. 21, except the body 4 isaffixed to the wire guide 26 at or near the distal opening 102. In otherembodiments, the catheter body 4 is affixed to both the wire guide 26 ator near the distal opening 102 and the shaft 16 at the exit hole 104.

As can be understood from FIG. 21 and as more clearly depicted in FIG.22, which is isometric views of the slides 30, 32 oriented to show theirportions of the passage 40 and their planar slide faces 48, the passage40 is large enough in diameter to displace over the outer diameter ofthe wire guide 26. As shown in FIGS. 21 and 22, a catheter body passage110 passes through the proximal portion 44 of each slide 30, 32, therebyallowing the slides 30, 32 to displace back and forth over the outersurface of the catheter body 4.

As indicated in FIG. 21, in one embodiment, the catheter body 4 has anopening 111 in its wall that allows the wires 38 to exit the body 4 andconnect to the slides 30, 32. In one embodiment, the wires 38 connect tothe slides 30, 32 via tension adjustment screws 54 as previouslydiscussed.

Due to the configuration of the slides 30, 32, the wire guide 26 and theshaft 16, the catheter body 4 may run uninterrupted the full length ofthe handle 2. As a result, electrical wiring 76 (see FIG. 19) and alumen 70 may be routed the full length of the handle 2 by way of thebody 4.

For a detailed discussion of another embodiment of the handle 2 of thepresent invention, reference is now made to FIGS. 23 and 24. FIG. 23 isan isometric view of the handle 2 exploded to show its variouscomponents. FIG. 24 is a longitudinal sectional elevation of the handle2 taken along section line YY of FIG. 23. Generally speaking, thefeatures of the handle 2 depicted in FIGS. 23 and 24 are similar to thefeatures of the handle depicted in FIG. 20, except the two embodimentsemploy different slider arrangements. For example, the embodimentsdepicted in FIGS. 1-22 employ parallel slides or members 30, 32 (i.e.,the slides 30, 32 exist within the handle 2 in a parallel orside-by-side arrangement). As will be understood from FIGS. 23 and 24and the following figures, in the embodiment of the handle 2 depicted inFIGS. 23 and 24, the slides or members 150, 152 exist within theadjustment knob 10 in a series arrangement (i.e., the slides 150, 152are not parallel or side-by-side to each other, but are orientedend-to-end along a longitudinal axis of the handle 2).

As shown in FIGS. 23 and 24, the adjusting knob 10 is pivotally coupledto the distal end of the mounting shaft (i.e., base portion) 16. Thewire guide 26 extends through the center of the adjusting knob 10 andthe mounting shaft 16. The catheter body 4 is coupled to the distal endof the wire guide 26 and, in one embodiment, extends through the wireguide 26 and out of the proximal end of the mounting shaft 16.

As shown in FIGS. 23 and 24, a distal slide 150 is located in a distalportion of the adjusting knob 10, and a proximal slide 152 is located ina proximal portion (i.e., hub portion 23) of the adjusting knob 10. Asillustrated in FIG. 24, the outer surface of each slide 150, 152 hasthreads 154 that mate with threads 156 on an interior surface of theadjusting knob 10.

As illustrated in FIG. 24, each deflection wire 38 a, 38 h travels alongthe interior of the wire guide 26 until it exits the wire guide 26 at ahole 157 in the sidewall of the wire guide 26. Each deflection wire 38a, 38 b then extends to the slide 150, 152 to which the deflection wire38 a, 38 b is attached. In one embodiment, in order to attach to a slide150, 152, a deflection wire 38 a, 38 b passes through a passage 159 inthe slide 150, 152 and attaches to a hollow tension adjustment screw 54via a knot 52 as previously described in this Detailed Description.

For a better understanding of the orientation of the threads 154, 156,reference is now made to FIGS. 25 and 26. FIG. 25 is the samelongitudinal sectional elevation of the adjusting knob 10 as it isdepicted in FIG. 24, except the adjusting knob 10 is shown by itself.FIG. 26 is a side elevation of the slides 150, 152.

As shown in FIGS. 25 and 26, in one embodiment, the distal slide 150 hasright hand threads 154 that engage right hand threads 156 in the distalportion of the adjusting knob 10, and the proximal slide 152 has lefthand threads 154 that engage left hand threads 156 in the proximalportion of the adjusting knob 10. Thus, as can be understood from FIGS.23-26, when the adjusting knob 10 is rotated relative to the mountingshaft 16 in a first direction about the longitudinal axis of the handle2, the slides 150, 152 will converge along the wire guide 26, therebycausing the first wire 38 to be placed into tension and the second wire38 to be compressed. As a result, the distal end 14 of the catheter body4 will deflect in a first direction. Similarly, when the adjusting knob10 is rotated in a second direction that is opposite from the firstdirection, the slides 150, 152 will diverge along the wire guide 26,thereby causing the first wire 38 to be compressed and the second wire38 to be placed into tension. As a result, the distal end 14 of thecatheter body 4 will deflect in a second direction generally oppositefrom the first direction.

In one embodiment, to prevent the slides 150, 152 from simply rotatingaround the wire guide 26 when the adjusting knob 10 is rotated, theslides 150, 152 and wire guide 26 are configured such that the slides150, 152 will displace along the wire guide 26, but not rotationallyaround it. For example, as indicated in FIG. 27A, which is a latitudinalsectional elevation of the handle 2 as taken along section line XX inFIG. 24, the wire guide 26 has a square cross section that mates with asquare hole 162 running the length of the slide 150, 152. Theinteraction between the square hole 162 and the square cross section ofthe wire guide 26 prevents a slide 150, 152 from rotating about the wireguide 26, but still allows the slide 150, 152 to displace along thelength of the wire guide 26.

In another embodiment, as shown in FIG. 27B, which is the samelatitudinal sectional elevation depicted in FIG. 27A, each slide 150,152 has a hole 162 with a circular cross section. Each hole 162 runs thelength of its respective slide 150, 152 and includes a key 160 thatextends into the hole 162 from the interior circumferential surface ofthe hole 160. The key 160 engages a groove or slot 158 that runs alongthe length of the wire guide 26 as depicted in FIG. 28, which is a sideelevation of one embodiment of the wire guide 26. The interactionbetween the key 160 and the slot 158 prevents a slide 150, 152 fromrotating about the wire guide 26, but still allows the slide 150, 152 todisplace along the length of the wire guide 26.

As shown in FIGS. 27A and 27B, a hollow shaft 165 extends through thewire guide 26. This allows a catheter body 4 with a lumen to extendcompletely through the handle 2 as shown in FIG. 24.

For a detailed discussion of another embodiment of the handle 2 that issimilar to the embodiment depicted in FIG. 23, reference is now made toFIGS. 29 and 30. FIG. 29 is a longitudinal sectional elevation of thehandle 2 as if taken through section line YY of FIG. 23. FIG. 30 is alongitudinal sectional plan view of the handle 2 as if taken throughsection line VV in FIG. 23 and wherein section line VV forms a planethat is perpendicular to the plane formed by section line YY in FIG. 23.

As illustrated in FIGS. 29 and 30, the handle 2 includes an adjustingknob 10 pivotally coupled to the distal end of the mounting shaft (i.e.,base portion) 16. In one embodiment, the adjusting knob 10 includes aproximal end 170, a distal end 172 and a threaded shaft 173, which isconnected to the proximal end 170 and extends distally along thelongitudinal axis of the adjusting knob 10. The threaded shaft 173includes a distal end 174, a proximal end 176, a series of right handthreads 178 along a distal portion of the shaft 173, and a series ofleft hand threads 180 along a proximal portion of the shaft 173.

As shown in FIGS. 29 and 30, a distal slide 150 is located in a distalportion of the adjusting knob 10, and a proximal slide 152 is located ina proximal portion (i.e., hub portion 23) of the adjusting knob 10. Eachslide has a hole 155 through which the threaded shaft 173 passes. Theinner circumferential surface of the hole 155 for the distal slide 150has right hand threads that mate with the right hand threads 178 on thedistal portion of the shaft 173. Similarly, the inner circumferentialsurface of the hole 155 for the proximal slide 152 has left hand threadsthat mate with the left hand threads 180 on the proximal portion of theshaft 173. In other embodiments, the locations for the left and rightthreads are reversed.

As can be understood from FIGS. 29, 30 and 31, which is an isometricview of one embodiment of the wire guide 26, a hollow center shaft 182extends from the distal end of the wire guide 26, through the threadedshaft 173 of the adjustment knob 10, and to the proximal end of the baseshaft 16. Thus, in one embodiment, a catheter body 4 may be routedthrough the lumen 165 of the wire guide's hollow center shaft 182 toexit the proximal end of the handle 2, as illustrated in FIGS. 29 and30.

As illustrated in FIG. 29, each deflection wire 38 a, 38 b travels alongthe interior of the wire guide 26 until it exits the wire guide 26 at ahole 157 in the sidewall of the wire guide 26. Each deflection wire 38a, 38 b then extends to the slide 150, 152 to which the deflection wire38 a, 38 b is attached. In one embodiment, in order to attach to a slide150, 152, a deflection wire 38 a, 38 b passes through a passage 159 inthe slide 150, 152 and attaches to a hollow tension adjustment screw 54via a knot 52 as previously described in this Detailed Description.

In one embodiment, as shown in FIG. 29, the deflection wire 38 b leadingto the proximal slide 152 passes through a second passage 161 in thedistal slide 150. The second passage 161 has sufficient clearance thatthe passage 161 may easily displace along the wire 38 b when the distalslide 150 displaces distally and proximally. The second passage 161serves as a guide that stiffens the wire 38 b and helps to reduce thelikelihood that the wire 38 b will bend when compressed.

As can be understood from FIGS. 29 and 30, when the adjusting knob 10 isrotated relative to the mounting shaft 16 in a first direction about thelongitudinal axis of the handle 2, the slides 150, 152 will convergealong the threaded shaft 173, thereby causing the first wire 38 a to beplaced into tension and the second wire 38 h to be compressed. As aresult, the distal end 14 of the catheter body 4 will deflect in a firstdirection. Similarly, when the adjusting knob 10 is rotated in a seconddirection that is opposite from the first direction, the slides 150, 152will diverge along the threaded shaft 173, thereby causing the firstwire 38 a to be compressed and the second wire 38 b to be placed intotension. As a result, the distal end 14 of the catheter body 4 willdeflect in a second direction generally opposite from the firstdirection.

In one embodiment, to prevent the slides 150, 152 from simply rotatingwith the threaded shaft 173 within the adjusting knob 10 when theadjusting knob 10 is rotated, the slides 150, 152 and wire guide 26 areconfigured such that the slides 150, 152 will displace along thethreaded shaft 173, but not rotationally within the adjusting knob 10.For example, as indicated in FIGS. 31 and 32, which is a latitudinalsectional elevation of the handle 2 as taken along section line WW inFIG. 29, the wire guide 26 has right and left semicircular portions 190that oppose each other and extend along the length of the hollow centershaft 182 of the wire guide 26. As shown in FIG. 32, the generallyplanar opposed faces 192 of the semicircular portions 190 abut againstthe generally planar side faces 194 of the slides 150, 152. Thisinteraction prevents a slide 150, 152 from rotating within theadjustment knob 10 when the knob 10 is rotated, but still allows theslide 150, 152 to displace along the length of the threaded shaft 173.

As can be understood from FIG. 36, which is a diagrammatic illustrationof the control handle 2 of the subject invention being employed in asurgical procedure on a patient 200, the distal end 14 of the catheterbody 4 is inserted into the patient 200 (e.g., intravenously via a bodylumen 202 of the patient 200, percutaneously, or via other avenues forentering the patient's body). The distal end 14 of the catheter body 4is advanced until positioned in a selected location within the patient200 (e.g., within a chamber 204 of the patient's heart 206 or otherorgan, with a body cavity of the patient, etc.). The distal end of thecatheter body 4 is then deflected by rotating the adjustment knob 10about a longitudinal axis of a base portion 16. As can be understoodfrom FIGS. 1-35, this causes the slides 30, 32 within the handle 2 todisplace along the longitudinal axis in opposite directions. Since eachslide 30, 32 is coupled to its respective deflection wire 38 and eachdeflection wire 38 runs through the catheter body 4 and is coupled tothe distal end 14, the distal end 14 of the catheter body 4 isdeflected.

Although a number of embodiments of this invention have been describedabove with a certain degree of particularity, those skilled in the artcould make numerous alterations to the disclosed embodiments withoutdeparting from the spirit or scope of this invention. For example, alljoinder references (e.g., attached, coupled, connected, and the like)are to be construed broadly and may include intermediate members betweena connection of elements and relative movement between elements. Assuch, joinder references do not necessarily infer that two elements aredirectly connected and in fixed relation to each other. It is intendedthat all matter contained in the above description or shown in theaccompanying drawings shall be interpreted as illustrative only and notlimiting. Changes in detail or structure may be made without departingfrom the spirit of the invention as defined in the appended claims.

What is claimed is:
 1. An apparatus for imparting a tensile force todeflect a distal portion of a catheter while maintaining its exteriordimensions, the apparatus comprising: a substantially hollow handle griphaving a tactile outer surface having a longitudinal axis; an adjustmentknob having a tactile outer surface coupled to the handle gripequidistant from the longitudinal axis, said adjustment knob beingrotatable about the longitudinal axis, wherein an interior surface of anaperture extending through the adjustment knob includes first threads; arelatively thin elongated flexible body having a distal end portion andhaving a proximal portion, wherein the proximal portion couples to thehandle grip; at least a pair of elongated members operatively coupled tothe adjustment knob and to the distal end portion; and means disposedwithin the handle grip and operatively coupled to the adjustment knobfor imparting a tensile force to one of the elongated members by linearmovement of an actuation member coupled to one of the elongate membersrelative to the adjustment knob when the adjustment knob is rotatedabout the longitudinal axis so that the distal end portion of theflexible body deflects from a first configuration to a secondconfiguration, the actuation member including second threads wherein thesecond threads mate with the first threads, wherein the tactile outersurfaces of the handle grip and the adjustment knob are substantiallyunchanged when the flexible body is disposed in the first and secondconfigurations.
 2. An apparatus according to claim 1, wherein the handlegrip includes one of generally oval and circular cross-sections.
 3. Anapparatus according to claim 1, wherein the adjustment knob includes agenerally circular cross-section.
 4. An apparatus for imparting atensile force to deflect a distal portion of a catheter whilemaintaining its exterior dimensions, the apparatus comprising: a handlegrip including a cross-section of generally predetermined exteriordimensions, and a longitudinal axis; a flexible elongate memberincluding proximal and distal end portions, with the proximal endportion being coupled to the handle grip; an adjustment knob including across-section of generally predetermined exterior dimensions, and beingrotatably coupled to the handle grip around the longitudinal axis of thehandle grip, said adjustment knob being rotatable about the longitudinalaxis, wherein an inner surface of a shaft extending through theadjustment knob includes first threads; and at least a pair of elongatedeflection members operably coupled to the adjustment knob and to thedistal end portion of the elongate member, wherein rotation of theadjustment knob about the longitudinal axis imparts a tensile force toat least one of the elongate deflection members by linear movement,relative to the adjustment knob, of an actuation member coupled to theat least one elongate deflection member, so as to cause the distal endportion of the flexible elongate member to deflect from a priorconfiguration while maintaining the generally predetermined exteriordimensions of the handle grip and the adjustment knob, the actuationmember including second threads for mating with the first threads.
 5. Anapparatus according to claim 4 further comprising a lumen extendingthrough said flexible elongate member terminating at an external openingat the distal end portion of said flexible elongate member.
 6. Anapparatus according to claim 4, wherein the elongate deflection membercomprises one of a pull wire, a filament, a braided cord, and aresin-based member.
 7. An apparatus according to claim 4, wherein theadjustment knob is operably coupled to one of an intermediate bodyportion and a distal portion of the handle grip.
 8. An apparatusaccording to claim 4, further comprising a hemostasis valve coupled tothe handle grip.
 9. An apparatus according to claim 4 further comprisingmeans for simultaneously imparting a tensile force to one of the pair ofelongate deflection members and for releasing a tensile force on theother one of the pair of elongate deflection members.
 10. An apparatusaccording to claim 9, wherein the interior surface forming the apertureis generally orthogonally oriented with respect to the longitudinal axisof the handle grip, the first threads comprising at least one set ofthreaded grooves which cooperate with the means for simultaneouslyimparting.
 11. An apparatus according to claim 9, wherein the means forsimultaneously imparting further comprises a pair of generally axiallydisplaceable members disposed within the handle grip, wherein rotationof the adjustment knob imparts opposing forces to the axiallydisplaceable members.
 12. An apparatus according to claim 4, furthercomprising at least one electrode coupled to the flexible elongatemember.
 13. An apparatus according to claim 4, wherein the flexibleelongate member comprises a biocompatible electrically insulativematerial.
 14. An apparatus according to claim 13, further comprising atleast one reinforcing element disposed within a portion of the flexibleelongate member.
 15. An apparatus according to claim 14, wherein thereinforcing element comprises braided members.
 16. An apparatusaccording to claim 15, wherein in the prior configuration, the distalend portion of the flexible elongate member is substantially straight.17. An apparatus according to claim 4, wherein the flexible elongatemember comprises a segment of at least one of a braided metallic wireand a non-metallic fiber.
 18. An apparatus according to claim 4, furthercomprising an anchor ring coupled to the distal portion of the flexibleelongate member, wherein the elongate deflection member comprises atleast one elongate pull wire coupled to the anchor ring.
 19. Anapparatus according to claim 5, wherein the lumen is sized andconfigured to receive a medical device and said external opening isaxially oriented.
 20. An apparatus according to claim 19, wherein themedical device comprises a catheter for delivering or receiving energy.